Central line, or central venous catheters (CVCs) are essential for patients undergoing hemodialysis, but they also pose significant risks, including catheter-related bloodstream infections (CRBSIs). These infections can lead to serious complications, increasing illness, disability, and healthcare costs. Based on the results of the LOCK-IT-100 trial, the FDA has approved DefenCath, a catheter lock solution to reduce the incidence of CRBSIs.*

Study Design and Results

The Phase 3 LOCK-IT-100 trial was conducted to evaluate the efficacy of DefenCath in preventing CRBSIs in adults with kidney failure undergoing hemodialysis via CVCs. 

A total of 806 patients were randomized to receive either DefenCath or heparin as a catheter lock solution after dialysis sessions. The results showed that:

• CRBSIs occurred in 2.3% of patients using DefenCath versus 8.0% in the heparin control group. 
• This represents a significant (71%) reduction in CRBSI rates with DefenCath.

The DefenCath group did experience a slight loss of catheter patency (openness, allowing for flow) and increase in the  need for thrombolytic agents (clot-busting drugs), but catheter removal rates were similar between the two groups.

Impact on Dialysis Patients 

According to the study authors, these findings suggest that DefenCath could become a valuable tool for improving safety and reducing infection-related complications in dialysis patients with central line catheters. 

By minimizing the risk of infections, DefenCath may help reduce hospitalizations and healthcare costs associated with managing CRBSIs, improving overall patient outcomes.

The slight increase in loss of catheter patency and the need for thrombolytic agents indicates that some patients may experience catheter function issues. This factor should be considered in the clinical management of patients using DefenCath, with careful monitoring for potential catheter complications.

Who Should and Shouldn’t Use DefenCath

DefenCath use is intended for:

• Adult patients with kidney failure undergoing chronic hemodialysis through a CVC who are at high risk of CRBSIs, and
• Patients who have not experienced recent antibiotic treatments, catheter exit-site infections, or recent thrombolytic therapy.

DefenCath use carries warnings for:

• Patients with known heparin-induced thrombocytopenia (HIT) or hypersensitivity to any of the components in DefenCath (taurolidine, heparin, or citrate).
• Patients with active systemic immunosuppression or a malignancy with a life expectancy of less than six months.

Patients and healthcare providers should also be mindful of potential side effects, including catheter malfunction, thrombocytopenia, and other hemodialysis-related complications, when considering DefenCath.

*CorMedix. (2024, June). Deliver superior results against infection vs standard of care (SOC). Retrieved from https://www.defencath.com/efficacy#efficacy-trial-design